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Questo studio è un registro di malattia non interventistico di pazienti adolescenti e adulti con dermatite atopica che iniziano o cambiano qualsiasi trattamento sistemico (ARMADA-AD)

30 ottobre 2026 aggiornato da: Sanofi

Registro della Dermatite Atopica di Pazienti Adulti e Adolescenti che Iniziano o Cambiano Trattamenti Sistemici

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Numero di telefono: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Luoghi di studio

  • Arabia Saudita
      • Jeddah, Arabia Saudita, 21452
        • Reclutamento
        • Erfan and Bagedo Hospital-Site Number : 6820002
        • Contatto:
        • Investigatore principale:
          • Ahmed Ismail Ebraheem Abdellateef
      • Jeddah, Arabia Saudita, 23421
        • Reclutamento
        • Medical Fakeeh-Site Number : 6820003
        • Contatto:
        • Investigatore principale:
          • Ayman Elgendi
      • Riyadh, Arabia Saudita, 12231
        • Reclutamento
        • King Fahad Medical City-Site Number : 6820001
        • Contatto:
        • Investigatore principale:
          • Mohammed Alajlan
  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Reclutamento
        • Origins Dermatology Centre-Site Number : 1240003
        • Investigatore principale:
          • Rachel Asiniwasis
        • Contatto:
  • Cina
      • Chongqing, Cina, 400016
        • Reclutamento
        • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
        • Contatto:
        • Investigatore principale:
          • Tao Cai
      • Shanghai, Cina, 200040
        • Reclutamento
        • Huashan Hospital, Fudan University-Site Number: 1560012
        • Investigatore principale:
          • Wei Li
        • Contatto:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100191
        • Reclutamento
        • Peking University Third Hospital-Site Number: 1560008
        • Investigatore principale:
          • Wenhui Wang
        • Contatto:
    • Guangdong
      • Shenzhen, Guangdong, Cina, 518033
        • Reclutamento
        • The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006
        • Contatto:
        • Investigatore principale:
          • Peimei Zhou
    • Hu'nan
      • Changsha, Hu'nan, Cina, 410008
        • Reclutamento
        • Xiangya Hospital of Central South University-Site Number : 1560001
        • Investigatore principale:
          • Juan Su
        • Contatto:
      • Changsha, Hu'nan, Cina, 410011
        • Reclutamento
        • The Second Xiangya Hospital of Central South University-Site Number: 1560014
        • Investigatore principale:
          • Yunsheng Liang
        • Contatto:
    • Shanxi
      • Xi’an, Shanxi, Cina, 710004
        • Reclutamento
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
        • Investigatore principale:
          • Songmei Geng
        • Contatto:
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Reclutamento
        • West China Hospital, Sichuan University- Site Number: 1560003
        • Investigatore principale:
          • Jingyi Li
        • Contatto:
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310006
        • Reclutamento
        • Hangzhou First People's Hospital-Site Number: 1560004
        • Investigatore principale:
          • Liming Wu
        • Contatto:
      • Hangzhou, Zhejiang, Cina, 310009
        • Reclutamento
        • The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007
        • Investigatore principale:
          • Xiaoyong Man
        • Contatto:
      • Ningbo, Zhejiang, Cina, 315010
        • Reclutamento
        • The First Affiliated Hospital of Ningbo University-Site Number : 1560009
        • Contatto:
        • Investigatore principale:
          • Bingjiang Lin
  • Emirati Arabi Uniti
      • Abu Dhabi, Emirati Arabi Uniti, 66566
        • Reclutamento
        • Mediclinic Hospital, AUH-Site Number: 7840004
        • Contatto:
        • Investigatore principale:
          • Hussein Abdel Dayem
      • Abu Dhabi, Emirati Arabi Uniti, 6222
        • Reclutamento
        • NMC Specialty Hospital-Site Number : 7840002
        • Contatto:
        • Investigatore principale:
          • Ahmed Ameen
      • Al Karama, Emirati Arabi Uniti, 50730
        • Reclutamento
        • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
        • Contatto:
        • Investigatore principale:
          • Srikumar Goturu
      • Dubai, Emirati Arabi Uniti, 00000
        • Reclutamento
        • Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003
        • Contatto:
        • Investigatore principale:
          • Amani Abdulla Rahma Alfalasi
  • Francia
    • Doubs
      • Besançon, Doubs, Francia, 25030
        • Reclutamento
        • CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010
        • Investigatore principale:
          • Francois Aubin
        • Contatto:
    • Drome
      • Valence, Drome, Francia, 26000
        • Reclutamento
        • Centre Hospitalier de Valence-Site Number: 2500005
        • Contatto:
        • Investigatore principale:
          • Anne Grange
    • Haut Rhin
      • Mulhouse, Haut Rhin, Francia, 68100
        • Reclutamento
        • GHRMSA - Hospital Emile Muller-Site Number : 2500006
        • Contatto:
        • Investigatore principale:
          • Catherine Michel
    • Reunion
      • Saint-Pierre, Reunion, Francia, 97448
        • Reclutamento
        • CHU de La Reunion-Site Number: 2500007
        • Investigatore principale:
          • Antoine Bertolotti
        • Contatto:
          • Antoine Bertolotti
    • Rhone
      • Romans-sur-Isère, Rhone, Francia, 26102
        • Reclutamento
        • Hopitaux Drome Nord-Site Number : 2500002
        • Investigatore principale:
          • Francois Skowron
        • Contatto:
    • Saone Et Loire
      • Chalon-sur-Saône, Saone Et Loire, Francia, 71100
        • Reclutamento
        • Centre Hospitalier William Morey-Site Number: 2500008
        • Contatto:
        • Investigatore principale:
          • Marie Dhers
    • Sarthe
      • Le Mans, Sarthe, Francia, 72037
        • Reclutamento
        • Centre Hospitalier du Mans-Site Number: 2500004
        • Contatto:
        • Investigatore principale:
          • Nathalie Beneton Benhard
  • Giappone
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Giappone, 763-0074
        • Reclutamento
        • Takeoka Dermatology Clinic- Site Number : 3920005
        • Contatto:
        • Investigatore principale:
          • Shintaro Takeoka
    • Osaka
      • Habikino-shi, Osaka, Giappone, 583-8588
        • Reclutamento
        • Osaka Habikino Medical Center-Site Number : 3920001
        • Investigatore principale:
          • Yoko Kataoka
        • Contatto:
    • Shizuoka
      • Hamamatsu, Shizuoka, Giappone, 430-0929
        • Reclutamento
        • JA-Shizuoka Enshu Hospital-Site Number: 3920003
        • Contatto:
        • Investigatore principale:
          • Chika Shibuya
  • Italia
      • Ancona, Italia, 60126
        • Reclutamento
        • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
        • Investigatore principale:
          • Oriana Simonetti
        • Contatto:
      • Novara, Italia, 28100
        • Reclutamento
        • Ospedale Maggiore di Novara-Site Number: 3800005
        • Contatto:
        • Investigatore principale:
          • Paola Savoia
      • Reggio Emilia, Italia, 42100
        • Reclutamento
        • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
        • Contatto:
        • Investigatore principale:
          • Vito Di Lernia
      • Roma, Italia, 00144
        • Reclutamento
        • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002
        • Contatto:
        • Investigatore principale:
          • Maria Concetta Fargnoli
  • Spagna
      • Alicante, Spagna, 03010
        • Reclutamento
        • Hospital General Universitario Dr. Balmis-Site Number: 7240005
        • Investigatore principale:
          • Juan Francisco Silvestre Salvador
        • Contatto:
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spagna, 08041
        • Reclutamento
        • Investigational Site Number : 7240006
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spagna, 38320
        • Reclutamento
        • Hospital Universitario de Canarias-Site Number: 7240008
        • Investigatore principale:
          • Ruperto Gonzalez Perez
        • Contatto:
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35244
        • Reclutamento
        • Cahaba Dermatology & Skin Health Center- Site Number : 8400006
        • Investigatore principale:
          • Vlada Groysman
        • Contatto:
      • Montgomery, Alabama, Stati Uniti, 36117
        • Reclutamento
        • River Region Dermatology and Laser- Site Number : 8400041
        • Investigatore principale:
          • Porcia Love
        • Contatto:
    • Arizona
      • Gilbert, Arizona, Stati Uniti, 85234
        • Reclutamento
        • San Tan Allergy & Asthma- Site Number : 8400031
        • Contatto:
        • Investigatore principale:
          • Sam Reed Shimamoto
      • Phoenix, Arizona, Stati Uniti, 85008
        • Reclutamento
        • Saguaro Dermatology- Site Number : 8400028
        • Investigatore principale:
          • Dathan Hamann
        • Contatto:
    • California
      • Bakersfield, California, Stati Uniti, 93301
        • Reclutamento
        • Kern Research, Inc.- Site Number : 8400047
        • Investigatore principale:
          • Tonny Tanus
        • Contatto:
      • Fremont, California, Stati Uniti, 94538
        • Reclutamento
        • Center for Dermatology Clinical Research- Site Number : 8400014
        • Investigatore principale:
          • Sunil Dhawan
        • Contatto:
      • Los Angeles, California, Stati Uniti, 90045
        • Reclutamento
        • Dermatology Research Associates - Los Angeles- Site Number : 8400020
        • Investigatore principale:
          • Howard Sofen
        • Contatto:
      • Northridge, California, Stati Uniti, 91325
        • Reclutamento
        • Northridge Clinical Trials, LLC- Site Number : 8400009
        • Investigatore principale:
          • Navid Ezra
        • Contatto:
      • Oakland, California, Stati Uniti, 94596
        • Reclutamento
        • Sunwise Clinical Research, LLC.- Site Number : 8400010
        • Contatto:
        • Investigatore principale:
          • Michael Abdel Malek
      • Pomona, California, Stati Uniti, 91767
        • Reclutamento
        • Empire Clinical Research, LLC- Site Number : 8400007
        • Contatto:
          • Usha Mantha
        • Investigatore principale:
          • Usha Mantha
      • San Diego, California, Stati Uniti, 92123
        • Reclutamento
        • University Clinical Trials- Site Number : 8400019
        • Investigatore principale:
          • Walter Nahm
        • Contatto:
    • Colorado
      • Wheat Ridge, Colorado, Stati Uniti, 80033
        • Reclutamento
        • Western States Clinical Research, Inc.- Site Number : 8400051
        • Investigatore principale:
          • Jeffrey Rumbyrt
        • Contatto:
    • Florida
      • Doral, Florida, Stati Uniti, 33172
        • Reclutamento
        • St. Jude Clinical Research- Site Number : 8400049
        • Contatto:
        • Investigatore principale:
          • Gustavo Torres
      • North Miami Beach, Florida, Stati Uniti, 33162-4708
        • Reclutamento
        • Ziaderm Research, LLC- Site Number : 8400021
        • Investigatore principale:
          • Tory Sullivan
        • Contatto:
    • Georgia
      • Macon, Georgia, Stati Uniti, 31217
        • Reclutamento
        • Skin Care Physicians of Georgia - Macon- Site Number : 8400034
        • Investigatore principale:
          • David Cohen
        • Contatto:
    • Illinois
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
        • Investigatore principale:
          • Dareen Siri
        • Contatto:
      • North Chicago, Illinois, Stati Uniti, 60064
        • Reclutamento
        • Rosalind Franklin University of Medicine and Science- Site Number: 8400056
        • Investigatore principale:
          • Raj Chovatiya
        • Contatto:
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48103
        • Reclutamento
        • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
        • Investigatore principale:
          • David Fivenson
        • Contatto:
      • Auburn Hills, Michigan, Stati Uniti, 48326
        • Reclutamento
        • Oakland Hills Dermatology- Site Number : 8400042
        • Investigatore principale:
          • Christofer Buatti
        • Contatto:
      • Bay City, Michigan, Stati Uniti, 48706
        • Reclutamento
        • Great Lakes Research Group - Bay City- Site Number : 8400052
        • Investigatore principale:
          • Brent Boyce
        • Contatto:
      • Caledonia, Michigan, Stati Uniti, 49316
        • Reclutamento
        • The Derm Institute of West Michigan- Site Number : 8400025
        • Investigatore principale:
          • Kristi Hawley
        • Contatto:
        • Contatto:
      • Detroit, Michigan, Stati Uniti, 48201
        • Reclutamento
        • Wayne State University - Detroit Medical Center- Site Number : 8400035
        • Investigatore principale:
          • Steven Daveluy
        • Contatto:
      • Waterford, Michigan, Stati Uniti, 48328
        • Reclutamento
        • Michigan Dermatology Institute - Waterford- Site Number : 8400013
        • Contatto:
        • Investigatore principale:
          • Cory Rubin
    • Missouri
      • Bolivar, Missouri, Stati Uniti, 65613
        • Reclutamento
        • Red River Research Partners, Llc- Site Number : 8400054
        • Contatto:
        • Investigatore principale:
          • Murphy Mastin
      • Kirksville, Missouri, Stati Uniti, 63501
        • Reclutamento
        • Cleaver Dermatology- Site Number : 8400033
        • Contatto:
        • Investigatore principale:
          • David Cleaver
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68510
        • Reclutamento
        • Allergy Asthma & Immunology- Site Number : 8400044
        • Investigatore principale:
          • Robert Szalewski
        • Contatto:
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89144
        • Reclutamento
        • Las Vegas Dermatology- Site Number : 8400002
        • Investigatore principale:
          • Harry Greenberg
        • Contatto:
    • New Hampshire
      • Portsmouth, New Hampshire, Stati Uniti, 03801
        • Reclutamento
        • Optima Research Portsmouth- Site Number : 8400032
        • Investigatore principale:
          • Abel Jarell
        • Contatto:
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Reclutamento
        • University Of New Mexico School Of Medicine- Site Number : 8400022
    • North Carolina
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Reclutamento
        • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
        • Contatto:
        • Investigatore principale:
          • Nicole Seminara Zambrzycka
      • Winston-Salem, North Carolina, Stati Uniti, 27104
        • Reclutamento
        • Wake Forest University Health Sciences- Site Number : 8400003
        • Investigatore principale:
          • Steven Feldman
        • Contatto:
    • North Dakota
      • Fargo, North Dakota, Stati Uniti, 58103
        • Reclutamento
        • Red River Research Partners - Fargo- Site Number : 8400037
        • Investigatore principale:
          • Michael Blankinship
        • Contatto:
    • Ohio
      • Marion, Ohio, Stati Uniti, 43302
        • Reclutamento
        • Dermatology Associates of Mid-Ohio- Site Number : 8400026
        • Contatto:
          • George Scott Drew
          • Numero di telefono: 740-244-8559
          • Email: spfxv@aol.com
        • Investigatore principale:
          • George Scott Drew
      • Mason, Ohio, Stati Uniti, 45040
        • Reclutamento
        • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
        • Investigatore principale:
          • Rocco Serrao
        • Contatto:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Reclutamento
        • UPMC - Department of Dermatology- Site Number : 8400024
        • Investigatore principale:
          • Joe Tung
        • Contatto:
    • Rhode Island
      • Warwick, Rhode Island, Stati Uniti, 02886
        • Reclutamento
        • Care Access Research - Warwick 2- Site Number : 8400045
        • Contatto:
        • Investigatore principale:
          • John Zwetchkenbaum
    • South Carolina
      • Spartanburg, South Carolina, Stati Uniti, 29307
        • Reclutamento
        • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
        • Contatto:
        • Investigatore principale:
          • Amylynne Frankel
    • Texas
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • Reveal Research Institute - Dallas- Site Number : 8400012
        • Investigatore principale:
          • Aaron Farberg
        • Contatto:
      • Fort Worth, Texas, Stati Uniti, 76244
        • Completato
        • Innovate Research - Fort Worth- Site Number : 8400016
      • Pflugerville, Texas, Stati Uniti, 78660
        • Reclutamento
        • Austin Institute for Clinical Research, Inc- Site Number : 8400030
        • Investigatore principale:
          • Edward Lain
        • Contatto:
      • Sugar Land, Texas, Stati Uniti, 77479
        • Reclutamento
        • Complete Dermatology - Sugar Land- Site Number : 8400001
        • Investigatore principale:
          • Bartley Gill
        • Contatto:
    • Utah
      • Bountiful, Utah, Stati Uniti, 84010
        • Reclutamento
        • Cope Family Medicine - Ogden Clinic- Site Number : 8400053
      • Springville, Utah, Stati Uniti, 84663
        • Reclutamento
        • Springville Dermatology - Springville- Site Number : 8400055
        • Contatto:
        • Investigatore principale:
          • Michael Peterson
    • Virginia
      • Falls Church, Virginia, Stati Uniti, 22042
        • Reclutamento
        • Fuchs Dermatology- Site Number : 8400027
        • Contatto:
        • Investigatore principale:
          • Aaron Fuchs
    • Washington
      • Mill Creek, Washington, Stati Uniti, 98012
        • Reclutamento
        • Frontier Dermatology Partners CRO LLC- Site Number : 8400011
        • Contatto:
        • Investigatore principale:
          • Eingun James Song
      • Seattle, Washington, Stati Uniti, 98105
        • Reclutamento
        • University of Washington - Roosevelt Location- Site Number : 8400005
        • Contatto:
        • Investigatore principale:
          • Vivian Shi

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with any atopic dermatitis severity will be invited to enroll in the registry after the decision has been made to initiate a new systemic medication for the first time or switch systemic therapies. Inclusion in the registry will not influence a patient's treatment course.

Descrizione

Inclusion Criteria:

  • Patients aged more than or equal to (≥) 12 years at the time of consent.
  • Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.
  • Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
  • Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.

Exclusion Criteria:

  • Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
  • Insufficient understanding of the study by the patient and/or parent/guardian.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Atopic Dermatitis

This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase [JAK] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Baseline to up to 60 months
Duration of Treatment
Lasso di tempo: Baseline to up to 60 months

The duration of AD treatments will be summarized descriptively.
Baseline to up to 60 months
AD Treatment Sequences
Lasso di tempo: Baseline to up to 60 months

The ordering of AD treatments will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Initiating AD Treatments with Reasons
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Interrupting AD Treatment
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Discontinuing AD Treatment
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Switching AD Treatments
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Augmenting AD treatment
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Modifying AD Treatment Dose
Lasso di tempo: Baseline to up to 60 months

The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)
Lasso di tempo: Baseline to up to 60 months

Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)
Lasso di tempo: Baseline to up to 60 months

Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Lasso di tempo: Baseline to up to 60 months

Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)
Lasso di tempo: Baseline to up to 60 months

Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change in Atopic Dermatitis Control Test (ADCT) from Baseline
Lasso di tempo: Baseline to up to 60 months

The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Baseline to up to 60 months
Change in Patient Global Impression of Severity (PGIS) from Baseline
Lasso di tempo: Baseline to up to 60 months

The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Baseline to up to 60 months
Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline
Lasso di tempo: Baseline to up to 60 months

The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Baseline to up to 60 months
Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline
Lasso di tempo: Baseline to up to 60 months

The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
Baseline to up to 60 months
Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline
Lasso di tempo: Baseline to up to 60 months

The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.
Baseline to up to 60 months
Remission of AD
Lasso di tempo: Baseline to up to 60 months

Total remission of all signs and symptoms of AD will be assessed.
Baseline to up to 60 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sociodemographic characteristics of Participants
Lasso di tempo: Baseline

Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.
Baseline
Ethnic Origin in Combination with Fitzpatrick Scale
Lasso di tempo: Baseline

The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin.
Baseline
Disease characteristics of Participants
Lasso di tempo: Baseline

History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected.
Baseline
Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)
Lasso di tempo: Baseline to up to 60 months

DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)
Lasso di tempo: Baseline to up to 60 months

The CDLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: Baseline to up to 60 months

PHQ-9 is a 9-item, validated, patient-reported questionnaire to assess depression which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). Possible scores range from 0 to 27 and are classified as 1-4: "minimal depression"; 5-9: "mild depression"; 10-14: "moderate depression"; 15-19: "moderately severe depression"; and 20-27: "severe depression".
Baseline to up to 60 months
Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ
Lasso di tempo: Baseline to up to 60 months

Work Productivity and Activity Impairment plus Classroom Impairment Questions (WPAI+CIQ) is a 10-item, patient-reported, validated questionnaire adapted for AD to measure impairments in work, classroom, and regular daily activities over a 7-day period.
Baseline to up to 60 months
Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Lasso di tempo: Baseline to up to 60 months

The 14-item TSQM-9 is a generic measure of treatment satisfaction, assessing side effects, effectiveness, convenience and global satisfaction, over the last 2 to 3 weeks, or since the patient has last used it. A lower score indicates lower satisfaction with treatment.
Baseline to up to 60 months
Visits with Specialty of Attending Healthcare Provider and Reason for Visit
Lasso di tempo: Baseline to up to 60 months

Health care resource utilization including visits with specialty of attending health care provider and reason for visit (example, disease flare-up, regular visit, prescription change, adverse event [AE]) will be assessed.
Baseline to up to 60 months
Hospitalizations for AD
Lasso di tempo: Baseline to up to 60 months

Hospitalization for AD will be assessed.
Baseline to up to 60 months
Prevalence of Comorbid Atopic Conditions
Lasso di tempo: Baseline to up to 60 months

Prevalence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Incidence of Comorbid Atopic Conditions
Lasso di tempo: Baseline to up to 60 months

Incidence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)
Lasso di tempo: Baseline to up to 60 months

ACQ-5 is a 5-item questionnaire used to assess asthma control [33]. Each question is rated on a 7-point scale (0=no impairment; 6=maximum impairment). The ACQ-5 score is calculated using the mean of the 5 items and ranges between 0 (well controlled asthma) to 6 (extremely poorly controlled asthma). The ACQ-5 will only be completed by patients with comorbid asthma.
Baseline to up to 60 months
Occurrence of Concomitant Medication use for AD and Selected Comorbidities
Lasso di tempo: Baseline to up to 60 months

The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.
Baseline to up to 60 months
Number of Adverse Events (SAEs)
Lasso di tempo: Baseline to up to 60 months

Number of patients experiencing AEs.
Baseline to up to 60 months
Number of Serious Adverse Events (SAEs)
Lasso di tempo: Baseline to up to 60 months

Number of patients experiencing SAEs.
Baseline to up to 60 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 novembre 2025

Completamento primario (Stimato)

30 gennaio 2034

Completamento dello studio (Stimato)

30 gennaio 2034

Date di iscrizione allo studio

Primo inviato

28 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

17 dicembre 2025

Primo Inserito (Effettivo)

18 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OBS18388
  • U1111-1311-1824 (Identificatore di registro: ICTRP)

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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